A significant number of NIH-funded projects are under the jurisdiction of an explicit data release policy. Such projects include: any project with direct costs of more than $500,00 per year, any genome-wide association study, and most community resource projects. (Community resource projects are large, costly projects designed from the outset to produce data and materials that will be of use to the broader scientific community, in contrast to hypothesis driven research.) Data release policies have generated controversy and confusion among scientists, particularly when the data in question come from human beings. Policies that favor public data release may be contravened by promises of privacy and confidentiality made to human research participants during the consent process. Whole genome data from humans raises particular problems, because it probably cannot be anonymized. Thus, scientists and ethics oversight personnel may view these data as potentially harmful if publicly released. The currently favored option for release of sensitive data involves a "controlled access" mechanism, which involves an administrative infrastructure for ascertaining who wants to use the data and for what purpose, and for communicating data restrictions to users. Each funded project develops its own specific data release plan. This pilot project will generate a variety of options for data release policies and plans, with a particular emphasis on release of whole genome data. It will do so by: (1) conducting approximately 20 interviews among people who have worked to develop data release policies, individuals who implement data release policies/plans, and researchers who work under these policies/plans;(2) using approaches to governance that have been developed by administrative law scholars, generate and evaluate a variety of options for releasing data from humans, particularly genomic data. These policy options will be disseminated in at least two articles, and through presentations at scholarly and public conferences. The data and scholarship generated in this project will provide the basis for larger empirical studies and policy planning conferences. The proposals of this project will pay particular attention to protecting the privacy and confidentiality interests of research participants, and to designing oversight processes that minimize administrative burdens on science. PUBLIC HEALTH RELEVANCE: This project has high public health significance because the utility and social value of large data sets depends on their availability. Data release policies determine the extent to which the large volumes of data that are generated with public funding are available for analysis by a wide variety of researchers. This project will design policies that promote rapid, broad data sharing while protecting the rights and interests of persons from whom the data were generated.